A Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone Metatarso-Phalangeal (MTP) Plate (CoLink® PCR MTP Plate) for the Treatment of Hallux Rigidus

Exclusion Criteria

• •1. Subjects who have previously undergone MTP fusion surgery or implant arthroplasty in the foot to be treated.
• •2. Subjects who require bi-lateral MTP fusion surgery.
• •3. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
• •4. Subjects with a known allergy to the material used in the instrumentation.
• •5. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
• •6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
• •7. Female subjects who are pregnant or lactating.
• •8. Subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes.
• •9. Subjects who are current smokers or have stopped smoking less than 6 months ago.
• •10. Subjects who are currently enrolled in a clinical study.